Evaluation of commercial Anti-SARS-CoV-2 neutralizing antibody assays in seropositive subjects

Saker, Kahina; Pozzetto, Bruno; Escuret, Vanessa; Pitiot, Virginie; Massardier-Pilonchéry, Amélie; Mokdad, Bouchra; Langlois‐Jacques, Carole; Rabilloud, Muriel; Alfaiate, Dulce; Guibert, Nicolas; Fassier, Jean‐Baptiste; Bal, Antonin; Trouillet‐Assant, Sophie; Trabaud, Mary‐Anne

doi:10.1016/j.jcv.2022.105169

Cited by 15 publications

(11 citation statements)

References 24 publications

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“…Further, GenScript cPass sVNT exhibited the best linear correlation with pVNT in samples collected from both infected and vaccinated individuals. These results are consistent with previous studies assessing the performance of GenScript sVNT compared to MNA and pVNT, demonstrating high specificity and even more sensitivity 7,30,33,34 . The two other assays, Dynamiker and Mindray NTAb, also exhibited a significant linear correlation with pVNT.…”

Section: Discussionsupporting

confidence: 92%

Evaluation of commercially available fully automated and ELISA-based assays for detecting anti-SARS-CoV-2 neutralizing antibodies

Al-Jighefee

Yassine²,

Al-Sadeq³

et al. 2022

Sci Rep

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Rapid and accurate measurement of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV2)-specific neutralizing antibodies (nAbs) is paramount for monitoring immunity in infected and vaccinated subjects. The current gold standard relies on pseudovirus neutralization tests which require sophisticated skills and facilities. Alternatively, recent competitive immunoassays measuring anti-SARS-CoV-2 nAbs are proposed as a quick and commercially available surrogate virus neutralization test (sVNT). Here, we report the performance evaluation of three sVNTs, including two ELISA-based assays and an automated bead-based immunoassay for detecting nAbs against SARS-CoV-2. The performance of three sVNTs, including GenScript cPass, Dynamiker, and Mindray NTAb was assessed in samples collected from SARS-CoV-2 infected patients (n = 160), COVID-19 vaccinated individuals (n = 163), and pre-pandemic controls (n = 70). Samples were collected from infected patients and vaccinated individuals 2–24 weeks after symptoms onset or second dose administration. Correlation analysis with pseudovirus neutralization test (pVNT) and immunoassays detecting anti-SARS-CoV-2 binding antibodies was performed. Receiver operating characteristic (ROC) curve analysis was generated to assess the optimal threshold for detecting nAbs by each assay. All three sVNTs showed an excellent performance in terms of specificity (100%) and sensitivity (100%, 97.0%, and 97.1% for GenScript, Dynamiker, and Mindray, respectively) in samples collected from vaccinated subjects. GenScript demonstrated the strongest correlation with pVNT (r = 0.743, R2 = 0.552), followed by Mindray (r = 0.718, R2 = 0.515) and Dynamiker (r = 0.608, R2 = 0.369). Correlation with anti-SARS-CoV-2 binding antibodies was variable, but the strongest correlations were observed between anti-RBD IgG antibodies and Mindray (r = 0.952, R2 = 0.907). ROC curve analyses demonstrated excellent performance for all three sVNT assays in both groups, with an AUC ranging between 0.99 and 1.0 (p < 0.0001). Also, it was shown that the manufacturer's recommended cutoff values could be modified based on the tested cohort without significantly affecting the sVNT performance. The sVNT provides a rapid, low-cost, and scalable alternative to conventional neutralization assays for measuring and expanding nAbs testing across various research and clinical settings. Also, it could aid in evaluating actual protective immunity at the population level and assessing vaccine effectiveness to lay a foundation for boosters' requirements.

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Section: Discussionsupporting

confidence: 92%

Evaluation of commercially available fully automated and ELISA-based assays for detecting anti-SARS-CoV-2 neutralizing antibodies

Al-Jighefee

Yassine²,

Al-Sadeq³

et al. 2022

Sci Rep

View full text Add to dashboard Cite

show abstract

“…Further, GenScript cPass sVNT exhibited the best linear correlation with pVNT in samples collected from both infected and vaccinated individuals. These results are consistent with previous studies assessing the performance of GenScript sVNT in comparison to MNA and pVNT, demonstrating high speci city and even more sensitivity [7,26,29,30]. The two other assays, Dynamiker and Mindray NTAb, also exhibited a signi cant linear correlation with pVNT.…”

Section: Discussionsupporting

confidence: 91%

Evaluation of a novel fully automated and ELISA- based assays for detecting anti- SARS- CoV-2 neutralizing antibodies

Al-Jighefee

Yassine

Al-Sadeq

et al. 2022

Preprint

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Background: Rapid and accurate measurement of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV2)-specific neutralizing antibodies (nAbs) is paramount for monitoring immunity in infected and vaccinated subjects. The current gold standard relies on pseudovirus neutralization tests which require sophisticated skills and facilities. Alternatively, recent competitive immunoassays measuring anti-SARS-CoV-2 nAbs are proposed as a quick and commercially available surrogate virus neutralization test (sVNT). Here, we report the performance evaluation of three sVNTs, including two ELISA-based assays and a novel automated bead-based immunoassay for detecting nAbs against SARS-CoV-2. Method: The performance of three sVNTs, including GenScript cPass, Dynamiker, and Mindray NTAb was assessed in samples collected from SARS-CoV-2 infected patients (n=160), COVID-19 vaccinated individuals (n=163), and pre-pandemic controls (n=70). Samples were collected from infected patients and vaccinated individuals 2-24 weeks after symptoms onset or second dose administration. Correlation analysis with pseudovirus neutralization test (pVNT) and immunoassays detecting anti-SARS-CoV-2 binding antibodies was performed. Receiver operating characteristic (ROC) curve analysis was generated to assess the optimal threshold for detecting nAbs by each assay. Results: All three sVNTs showed an excellent performance in terms of specificity (100%) and sensitivity (100%, 97.0%, and 97.1% for GenScript, Dynamiker, and Mindray, respectively) in samples collected from vaccinated subjects. GenScript demonstrated the strongest correlation with pVNT (r=0.743, R2=0.552), followed by Mindray (r=0.718, R2=0.515) and Dynamiker (r=0.608, R2=0.369). Correlation with anti-SARS-CoV-2 binding antibodies was variable, but the strongest correlations were observed between anti-RBD IgG antibodies and Mindray (r=0.952, R2=0.907). ROC curve analyses demonstrated excellent performance for all three sVNT assays in both groups, with an AUC ranging between 0.99 and 1.0 (p <0.0001). Also, it was shown that the manufacturer’s recommended cutoff values could be modified based on the tested cohort without significantly affecting the sVNT performance.Conclusion: The sVNT provides a rapid, low-cost, and scalable alternative to conventional neutralization assays for measuring and expanding nAbs testing across a wide range of research and clinical settings. Also, it could aid in evaluating actual protective immunity at the population level and assessing vaccine effectiveness to lay a foundation for boosters’ requirements.

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“…However, the methods were performed 0-2 months after SARS-CoV-2 natural infection ( Jung et al, 2021 ). In contrast, a study by Saker et al showed sensitivity between 49.2-66.7% and specificity between 68.4-77.3% of a qualitative immunochromatographic method (Dynamiker Biotechnology) compared to quantitative ELISA (TECO) ( Saker et al, 2022 ).…”

Section: Discussionmentioning

confidence: 91%

Comparison of a rapid fluorescence immunochromatographic test with an enzyme-linked immunosorbent assay for measurement of SARS-CoV-2 spike protein antibody neutralizing activity

Filippatos

Tatsi²,

Papagiannopoulos

et al. 2023

Journal of Virological Methods

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Evaluation of commercial Anti-SARS-CoV-2 neutralizing antibody assays in seropositive subjects

Cited by 15 publications

References 24 publications

Evaluation of commercially available fully automated and ELISA-based assays for detecting anti-SARS-CoV-2 neutralizing antibodies

Evaluation of commercially available fully automated and ELISA-based assays for detecting anti-SARS-CoV-2 neutralizing antibodies

Evaluation of a novel fully automated and ELISA- based assays for detecting anti- SARS- CoV-2 neutralizing antibodies

Comparison of a rapid fluorescence immunochromatographic test with an enzyme-linked immunosorbent assay for measurement of SARS-CoV-2 spike protein antibody neutralizing activity

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